Remotely-activated vertebroplasty injection device

• US 8,066,713 B2
• Filed: 03/31/2003
• Issued: 11/29/2011
• Est. Priority Date: 03/31/2003
• Status: Expired due to Term

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Inventors: Pellegrino, Richard, Crombie, John, DiMauro, Thomas M.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US10/405,113
• Publication Number:
  US 20040193171A1
• Time in Patent Office: 3,165 Days
• Field of Search: 606 92- 95, 604/131, 604151-152, 604154-155, 604/187, 604/218, 604/224, 604/228, 604/232, 604/233, 604/234, 604/235, 604/240, 604/19, 604/181, 604/223, 128/DIG.1, 222/309, 222/372, 222/383.1, 222/44, 222/48, 222256-263, 222/174, 623/23.62, 401118-119, 745/005, 745/015.R, 745/015.H
• US Class Current: 606/94
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/48 Operating or control means, e.g. from outside the body, control of sphincters
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30523 by means of meshing gear teeth
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A remotely-activated injection device for use in vertebroplasty is provided to inject a flourescent probe material into a patient. The injection device includes a pump defining an injection chamber having an exit opening; an actuator; and a cable having a first end coupled to the actuator, and a second end remotely engaging the pump. The actuator remotely controls the pump by responsive movement of the cable to thereby cause injection of a flourescent probe material from the injection chamber of the pump through the exit opening to the patient.

Claims

1. A remotely-activated device for injecting a bone cement into a patient, comprising:

a pump defining an injection chamber having an exit opening, the pump having a bone cement for injection being located in the injection chamber, and a piston for driving the bone cement for injection through the exit opening;

a hollow bone needle extending from the exit opening for transferring the bone cement for injection directly to a patient;

a remote actuator, separate from the pump, and including a base and a lever, the lever having a first portion pivotally-connected to the base; and

a housing connecting the actuator to the pump across a distance;

whereby pivotal movements of the lever apply a force across the distance through the housing to cause responsive movement of the piston to drive the bone cement for remote injection through the exit opening and wherein the piston driver includes a gear mechanism.

2. The device of claim 1 further comprising a cable having a first end coupled to the actuator, and a second end engaging the pump, the actuator controlling the pump by mechanical force of the cable on the pump, causing injection of the bone cement from the injection chamber of the pump through the exit opening.

3. The device of claim 2 further comprising a piston driver engaging the piston to allow axial movement of the piston along a first axis defined by first and second end portions of the injection chamber, wherein the second end of the cable engages the piston driver and the actuator controls the piston driver by responsive movement of the cable to thereby cause axial movement of the piston toward the exit opening of the injection chamber, thereby further causing injection of the bone cement through the exit opening.

4. The device of claim 1 wherein the gear mechanism comprises:

a wheel having a perimeter of teeth, the wheel engaging first and second opposing elements;

the first opposing element having an end mounted to the piston;

the second opposing element having an end coupled to the second end of the cable, whereby responsive movement of the cable causes axial movement of the second element, thereby causing rotational movement of the wheel, thereby further causing axial movement of the first element and the piston toward the exit opening of the injection chamber.

5. The device of claim 1, further comprising an anchor for coupling the pump to a patient.

6. The device of claim 5, further comprising:

a needle coupled to the exit opening in the second end portion of the injection chamber; and

the needle being guided to the patient through the anchor.

14. The device of claim 1, wherein the distance is between about one foot and ten feet.

15. The device of claim 1, wherein the distance is at least about two feet.

16. The device of claim 1, wherein the distance is at least about five feet.

17. The device of claim 1, wherein the remote actuator is proximal with respect to the pump from the perspective of an operator of the device.

18. The device of claim 1, wherein the remote actuator base is a handheld base and the remote actuator is configured to be held and activated by hand.

19. The device of claim 1, wherein the distance is at least about one foot.

20. The device of claim 1, wherein the distance is between about one foot and ten feet.

21. The device of claim 1, wherein the distance is at least about two feet.

22. The device of claim 1, wherein the distance is at least about five feet.

23. The device of claim 1, wherein the distance is sufficient to allow an operator to operate the remote actuator outside the range of a fluoro-field directed at the pump.

24. The device of claim 1, further comprising an imaging system directed at the pump.

25. The device of claim 24, wherein the imaging system is fluoroscopic.

26. The device of claim 25, wherein the distance is sufficient to allow an operator to operate the remote actuator outside the range of a fluoro-field directed at the pump.

29. The device of claim 1, wherein the bone cement comprises PMMA.

30. The device of claim 1, wherein the bone cement has a paste-like consistency.

7. A method for remotely injecting a bone cement comprising:

guiding a hollow bone needle to a desired location within a patient'"'"'s vertebral body;

placing a bone cement for injection into an injection chamber of a device, the device comprising;

a pump defining the injection chamber having an exit opening, the device further having a piston for driving the bone cement for injection through the exit opening;

the hollow bone needle extending from the exit opening for transferring the bone cement for injection directly to a patient;

a remote actuator spaced a distance apart from the pump and including a base and a lever, the lever having a first portion pivotally-connected to the base; and

a housing connecting the actuator to the pump;

whereby pivotal movements of the lever apply a force through the housing to cause responsive movement of the piston to drive the bone cement for injection through the exit opening;

pivotally moving the lever to apply a force across the distance through the housing to cause responsive movement of the piston to drive the bone cement for injection through the exit opening applying an imaging device to image the injection of bone cement at least at the desired location;

wherein the actuator is outside of an imaging field created by the application of the imaging device.

8. The method of claim 7, further comprising:

anchoring the device to a patient.

9. The method of claim 7, wherein the imaging device is a fluoroscope.

10. The method of claim 7, wherein the remote actuator base is a handheld based and the remote actuator is configured to be held and activated by hand.

11. The method of claim 10, wherein pivotally moving the lever comprises an operator holding the base and squeezing the lever by hand.

12. The method of claim 7, wherein the remote actuator is proximal with respect to the pump from the perspective of an operator of the device.

13. The method of claim 7, wherein the distance is at least about one foot.

27. The method of claim 7, wherein the bone cement comprises PMMA.

28. The method of claim 7, wherein the bone cement has a paste-like consistency.